Cleared Traditional

K991615 - POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE

K991615 is an FDA 510(k) clearance for POLYURETHANE POWDER FREE DENTAL EXAMINA..., manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K991615 · Maxxim Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
81d
Days
Class 1
Risk

K991615 is an FDA 510(k) clearance for the POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE M.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Maxxim Medical (Oldsmar, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maxxim Medical devices

FDA 510(k) Submission Details - K991615

510(k) Number K991615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date July 30, 1999
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1145
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K991615.
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
K991845 · Omnigrace , Ltd. · Aug 1999
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
K991846 · Omnigrace , Ltd. · Aug 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
K991981 · Alliance Rubber Products Sdn. Bhd. · Aug 1999
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
K992177 · Pt. Berlian Glovindo · Jul 1999
NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K991821 · Ning BO Yujiang Rubber & Plastic Co. · Jul 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876 · Brightway Holdings Sdn. Bhd. · Jun 1999